Revance Provides Corporate Update and Anticipated Milestones for 2020
Acceptance of BLA Submission for DaxibotulinumtoxinA for Injection (DAXI) in Glabellar Lines Expected Q1 2020 – In
November 2019, Revance submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration( FDA) for DAXI in the treatment of moderate-to-severe frown lines. In the Phase 3 pivotal program, the median time to loss of none or mild wrinkle severity was 24 weeks and the median time to return to baseline wrinkle severity was approximately 28 weeks. Revance anticipates acceptance of the submission in the first quarter and projects potential approval in the fourth quarter of 2020. Subject to approval, the company plans to initiate commercialization activities before year end.
New Phase 2 Trial Initiated for Treatment of Full Upper Face – In
December 2019, Revance initiated a new open-label Phase 2 trial for treatment of the full upper face – glabellar (frown), lateral canthal (crow’s feet), and forehead lines combined. This trial is being conducted to understand the safety and efficacy, including potential dosing and injection patterns, of DAXI, covering the full upper face. The company expects completion of enrollment in first quarter, with topline results in fourth quarter of 2020. This trial is in addition to the existing open-label Phase 2 clinical trials that the company has already fully enrolled in forehead lines and crow’s feet.
Enrollment Completed in Phase 2 Plantar Fasciitis Trial – In
December 2019, Revance enrolled the last of 155 subjects in its Phase 2 placebo-controlled clinical trial of DAXI for the management of plantar fasciitis. Plantar fasciitis is characterized by inflammation and sharp, constant pain in the heel that can become incapacitating. The company expects to report topline results for the Phase 2 trial in the second half of 2020.
Close of Public Offering of Common Stock – Revance closed its underwritten public offering of 7,475,000 shares of its common stock at a price to the public of
$17.00per share, including the exercise in full by the underwriters of their option to purchase 975,000 additional shares. The gross proceeds to the company from the offering, before deducting the underwriters’ discounts, commissions and other estimated offering expense payable by Revance, were approximately $127.1 million, which is reflected in the unaudited January 3, 2020cash, cash equivalents and short-term investments balance of $306.1 million. The company’s common shares outstanding was 53.4 million as of January 3, 2020.
“This is a very exciting and pivotal year for Revance, with not only a number of significant clinical data read-outs, but also the expected U.S. approval and launch of our next-generation neuromodulator product, DAXI,” said
Near-Term Milestone Expectations
Acceptance by the
FDAof BLA submission for DAXI in glabellar lines expected in 1Q 2020. Potential approval anticipated in 4Q 2020.
- Topline results from Phase 2 open-label study of DAXI in forehead lines expected in 2Q 2020.
- Topline results from Phase 2 open-label study of DAXI in lateral canthal lines (crow’s feet) expected in 2Q 2020.
- Completion of patient enrollment in Phase 2 full upper face open-label trial expected in 1Q, with topline results in 4Q of 2020.
- Completion of patient enrollment in Phase 2 of DAXI in upper limb spasticity study expected mid-year 2020.
- Topline results from Phase 3 study of DAXI in cervical dystonia expected in 2H 2020.
- Topline results from Phase 2 study of DAXI in plantar fasciitis expected in 2H 2020.
Decision by Mylan on continuation of biosimilar to BOTOX® program expected by
April 30, 2020.
* Source: DRG –
BOTOX® is a registered trademark of
This press release contains forward-looking statements, including statements related to the cash and investment balance as of
Revance Therapeutics, Inc.:
Sara Fahy, 949-887-4476
Jenifer Slaw, 347-971-0906
Nadine Tosk, 504-453-8344